Cystatin C Assay Market Share, Size, Trends, Industry Analysis Report, By Product (Kits, Reagents, and Analyzers); By Sample Type; By Method; By Application, By End-user, By Region; Segment Forecast, 2024- 2032
- Published Date:Mar-2024
- Pages: 116
- Format: PDF
- Report ID: PM4650
- Base Year: 2023
- Historical Data: 2019 – 2022
Report Outlook
Cystatin C assay market size was valued at USD 323.80 million in 2023. The market is anticipated to grow from USD 342.20 million in 2024 to USD 590.29 million by 2032, exhibiting the CAGR of 7.1% during the forecast period.
Market Overview
The growing burden of chronic kidney disease (CKD) is one of the major factors driving the industry growth of the cystatin C assay market. Factors such as changes in lifestyle and the rising geriatric population are the primary reasons attributed to the growing prevalence of CKD. Moreover, several benefits associated with the use of the cystatin C test over the creatinine test are fueling the adoption of the cystatin C assay. Furthermore, the rising number of patients suffering from diabetes, hypertension, heart diseases, glomerulonephritis, and obesity is expected to increase the patient pool of chronic kidney diseases, thereby fueling the cystatin C assay market expansion.
- According to the IDF Diabetes Atlas (2021) by the International Diabetes Federation (IDF), around 783 million people are suffering from diabetes by 2045, with an increase of 46.0% compared to 2021.9
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The strong focus of the government towards the spending on kidney diseases coupled with the high prevalence of various kidney disorders in developed countries is expected to contribute to the cystatin C assay market growth in the projected years. Moreover, the early screening of kidney function tests in sick babies and the aging population is expected to increase the demand for cystatin C tests. Furthermore, increasing accessibility and convenience to cystatin C assays owing to the emergence of various diagnostic technologies such as point-of-care testing will also prove beneficial for the market growth.
However, several healthcare facilities with limited resources may find it financially difficult to develop, produce, and implement cystatin C tests due to the related costs, as well as the need for equipment and training. Moreover, the high cost associated with cystatin C tests compared to creatinine will limit the industry’s growth in the coming years. Furthermore, the lack of skilled professionals to conduct tests and interpret accurate results is expected to hamper the adoption of cystatin C assays in the coming years.
Growth Factors
The increasing prevalence of chronic kidney diseases is expected to boost the cystatin C assay market growth
Cystatin C is a new marker for the diagnosis of kidney-related problems. The growing prevalence of chronic kidney disease (CKD) in developed nations such as the U.S. and Europe is primarily boosting the demand for cystatin C assay. Further, the presence of a large patient pool suffering from chronic kidney disease and rising market trends toward awareness of chronic diseases will contribute to the growth of the Cystatin C assay market during the projected period. For instance, according to the recently published statistics by the Centers for Disease Control & Prevention (CDC), in 2023, approximately 35.5 million people in the U.S. are estimated to have CKD.
Health problems such as loss of appetite, weakened immune system, anemia, low calcium levels, and high phosphorus levels arise due to low kidney function, which makes the early screening of kidney disease more important. The growing need for early detection of kidney diseases will increase the test volume, thereby fueling the growth of the cystatin C assay market.
Several advantages associated with the use of the cystatin C test over the creatinine test will drive the market growth
The tests such as cystatin C and creatinine are used to screen and monitor kidney dysfunction. Creatinine test has been used as a traditional screening method to investigate kidney problems. However, the use of the cystatin C test offers several vital benefits, which are expected to increase the preference for these tests, thereby spurring the demand for cystatin C assay. For instance, factors such as race, diet, and muscle mass have no significant effect on cystatin C levels.
Moreover, creatinine measurements could not be accurate in people with liver cirrhosis, extreme obesity, amputated limbs, and decreased muscle mass (elderly and children). Unlike creatinine, cystatin C is not affected by diet or body mass, making it a more accurate indicator of kidney function. Accordingly, based on the aforementioned factors and the benefits of cystatin C over creatinine, the industry forecast expects an increase in the demand for cystatin C assay during the forecast period.
Restraining Factors
Cystatin C assay's high costs are predicted to impede the market expansion
The expenses involved in the research, development, and validation of cystatin C assay can challenge the industry players, thereby limiting the overall market growth. Moreover, financial challenges related to the development, manufacturing, and implementation, coupled with the necessary training and equipment for cystatin C assay, are some of the biggest challenges for market players.
Furthermore, the high cost of cystatin C reagents over creatinine reagents will restrain growth. For instance, according to the National Center for Biotechnology Information (NCBI), in August 2022, in the U.S., creatinine tests cost about USD 0.50 per test, while cystatin C reagents range from USD 5.0 to USD 10.0 per test. Such high costs are likely to decline the test volume, thereby hampering the cystatin C assay market growth.
Report Segmentation
The market is primarily segmented based on product, sample type, method, application, end-user, and region.
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By Product Insights
The kits segment is expected to witness significant growth during the forecast period
The industry forecast predicts the kits segment to witness significant growth at the highest CAGR during the forecast period. The primary factors driving the growth of this segment are convenience and ease of use of kits. Moreover, the purpose of offering a complete solution for carrying out the cystatin C assay and the high preference of healthcare facilities and laboratories to adopt ready-to-use solutions are expected to contribute to the growth of the kits segment in the projected years. Furthermore, the research and development activities by manufacturers to introduce new and high-quality testing kits will also fuel segmental growth.
By Sample Type Insights
Blood segment dominated the largest market share in 2023
Based on sample type, the blood segment dominated the market share in 2023. High accuracy and widespread adoption of blood tests are the primary factors contributing to the dominance of the blood segment. Accurate assessment of renal function by cystatin C tests requires the use of blood as a sample. It enables the sensitive identification of changes in GFR and ensures the clinical significance of the data through quantitative and standardized measures. Thus, a high preference for blood samples by clinical laboratories is expected to contribute to segmental growth in the upcoming years.
By Method Insights
Enzyme-linked immunosorbent assay (ELISA) segment generated the largest cystatin C assay market worth
The enzyme-linked immunosorbent assay (ELISA) segment generated the largest cystatin C assay market worth. The widespread adoption of this method for quantifying the concentration of cystatin C in different samples is responsible for a significant share of the segment. In developing countries, the prevalence of chronic kidney disease is increasing significantly owing to the growing burden of hypertension and diabetes mellitus. Factors such as simplicity in process and easy availability of ELISA tests are attracting researchers as well as clinicians from developing countries. Thus, the factors above contribute to the growth of segmental share.
By End-user Insights
The hospitals segment emerged as the largest market worth-generating end-user
In 2023, the hospitals segment held a significant share of the cystatin c assay market. The large patient population and easy access are responsible for the largest share of the segment. Moreover, the strict quality control and assurance guidelines followed by hospitals for performing cystatin c tests are expected to increase the demand for cystatin C assay in this end-user setting. Furthermore, greater reliability and guaranteed precision associated with the cystatin C tests conducted in hospitals drive segmental growth. \
Regional Insights
North America emerged as the largest market in 2023
North America dominated the market in 2023. The dominance of this region is majorly attributed to factors such as the high prevalence of chronic kidney disease among the geriatric population and the presence of a large patient pool suffering from diabetes and other chronic disorders. For instance, according to the Centers for Disease Control & Prevention (CDC), people aged 65 years and above are more likely to have CKD in the U.S. Moreover, a sophisticated healthcare system, extensive availability of state-of-the-art diagnostic tools, and high awareness about early screening of diseases are the factors that will help the region to maintain its dominant position in the market.
Asia Pacific region is expected to register the highest CAGR during the forecast period
Asia Pacific region is expected to register the highest CAGR during the forecast timeframe. The rising number of patients suffering from kidney diseases, coupled with increasing awareness related to the early detection of these diseases, is expected to propel the demand for cystatin C assay in the projected years. For instance, according to PACE Hospitals in 2023, the approximate prevalence of chronic kidney disease in India is 800 per one million people. Aging populations and rising occurrence rates of hypertension and diabetes are also contributing to the chronic kidney disease epidemic, thereby increasing the demand for cystatin C assay.
Key Market Players & Competitive Insights
Few companies dominated the cystatin C assay market in 2023
The market is consolidated in nature owing to the dominance of several major players. These companies, along with other small and medium-sized companies, are continuously focused on strategic developments such as new product launches, acquisitions, and collaborations in order to improve their market size.
Some of the major players operating in the global market include:
- Abbott (U.S.)
- Abcam plc (UK)
- Agilent Technologies, Inc (U.S.)
- Beckman Coulter, Inc. (U.S.)
- bioMérieux, S.A (France)
- Bio-Rad Laboratories, Inc (U.S.)
- Bio-Techne (U.S.)
- DiaSys Diagnostic Systems GmbH (Germany)
- Randox Laboratories Ltd. (UK)
- Roche Diagnostics Limited (Switzerland)
- Siemens Healthcare Private Limited (India)
- Sino Biological, Inc. (China)
- Thermo Fisher Scientific Inc. (U.S.)
Recent Developments in the Industry
- In August 2022, Bloom Diagnostics announced the launch of its new kidney test. This test is used for the quantitative assessment of cystatin C in whole blood.
Report Coverage
The cystatin C assay market report emphasizes on key regions across the globe to provide better understanding of the product to the users. Also, the report provides market insights into recent developments, market trends and analyzes the technologies that are gaining traction around the globe. Furthermore, the report covers in-depth qualitative market analysis pertaining to various paradigm shifts associated with the transformation of these solutions.
The report provides detailed market analysis while focusing on various key aspects such as competitive analysis, product, sample type, method, application, end-user, and their futuristic growth opportunities.
Cystatin C Assay Market Report Scope
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Report Attributes |
Details |
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Market size value in 2024 |
USD 342.20 million |
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Revenue forecast in 2032 |
USD 590.29 million |
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CAGR |
7.1% from 2024 – 2032 |
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Base year |
2023 |
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Historical data |
2019 – 2022 |
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Forecast period |
2024 – 2032 |
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Quantitative units |
Revenue in USD million and CAGR from 2024 to 2032 |
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Segments covered |
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Regional scope |
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Competitive Landscape |
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Report Format |
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Customization |
Report customization as per your requirements with respect to countries, region and segmentation. |
FAQ's
The Cystatin C Assay Market report covering key segments are product, sample type, method, application, end-user, and region.
Cystatin C Assay Market Size Worth $590.29 Million By 2032
Cystatin C assay market exhibiting the CAGR of 7.1% during the forecast period.
North America is leading the global market
key driving factors in Cystatin C Assay Market are Increasing prevalence of chronic kidney diseases
